Objectives: Urinary stress incontinence (USI) is a discomforting condition that negatively affects the quality of life of many female individuals and frequently treated by surgical intervention. The incontinence curative operations revolutionized at 1995, with the introduction of the first retro-pubic sub-mid urethral synthetic slings, intra-vaginal sling-plasty (IVS) and tension free vaginal tape (TVT), by Ulmsten and Petros. This was later proposed to be done trans-obturator (TOT), for avoiding operative bladder injuries such as perforation (5.5% were attributed to the older technique and 0.3% to TOT) according to Cochrane review in 2009. Among other peri-operative untoward outcomes attributed to the commonly used anti-incontinence TOT are the dyspareunia, thigh and groin pain. This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene laser cut tape) to Serasis procedure (softly knitted monofilament non-absorbable polypropylene) for the cure of USI. The purpose of this study is to evaluate the feasibility, the safety, the cure rate, and postoperative pain of both procedures, as well as digital ability to palpate the implanted tapes and on physical examination. We assume that production of pain during palpation of the tape might predict dyspareunia in our patients. Materials and Methods: This is a two arm, prospective and randomized comparative study. Ninety-nine women were recruited for the study and followed for one year after the surgery. Data was collected from the patientís medical charts and, in addition, the patients were interviewed by using three different questionnaires [Pain Questionnaire (Pain Q), Urinary Distress Inventory - Short Form (UDI-6), Incontinence Impact Questionnaire - Short Form (IIQ-7)] at different time intervals. In addition, physical examinations were performed before and after the operations. Results: Cure rates at three months and one-year post surgery were similar between both groups based on questionnaires and physical exams. A trend of higher palpation score was documented with TVT-Abbrevo group vs. Serasis group (5.6% vs. 0.0%, p=NS) one-year post surgery. Replies to the pain questionnaire showed no significant difference between the two groups. Surgery characteristics-needle passing in the tissue was more difficult in Serasis group (23.4% vs. 0.0%, p=NS) than in TVT- Abbrevo group, however, blood loss was more prominent in TVT-Abbrevo group (1- sided p-value 0.046). One procedure failed in TVT-Abbrevo and Serasis groups meaning inadequate improvement, leakage persisted one year after the surgery. Conclusion: Based on the results, Serasis softly knitted polypropylene tape might be a better choice than TVT-Abbrevo laser cut polypropylene for the treatment of female USI due to less unfavorable outcomes.
Corresponding Author: NEUMAN M.|